Moser Konstantin, Bauch Felix, Richter Manon, Brütting Christine, Bauer Alexander, Vinker Shlomo, Deutsch Tobias, Frese Thomas
Institute of General Practice and Family Medicine, Center of Health Sciences, Martin-Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112 Halle (Saale), Germany.
Family Medicine Department, Tel-Aviv University, Ramat Aviv, 69978 Tel Aviv, Isreal.
J Family Med Prim Care. 2024 Sep;13(9):4056-4065. doi: 10.4103/jfmpc.jfmpc_1957_23. Epub 2024 Sep 11.
The growing importance of collecting Broad Consent (BC) for research utilizing electronic health records in Germany has brought attention to the need for a deeper understanding of potential selection bias in the process. Since 2020, the BeoNet-Halle outpatient database has been collecting anonymous and pseudonymous patient data from primary care and specialty practices throughout Germany, with the practice being an integral part of this data collection effort. The primary objective of the pilot study is to explore potential socioeconomic discrepancies between patients who provided BC and the general practice population.
This is a single-center, cross-sectional study. The study was performed with patients from one Medical Care Center including eight GPs. We categorized patients with at least one interaction with a general practitioner from March 2021 to January 2023 into two sets: patients who approved BC versus a randomly chosen representative sample (RS) of non-BC inquirers. We mailed a sociodemographic survey to both groups.
A total of 561 patients were analyzed, with the BC group responding more actively (60.7%) than the RS group (29.7%). Age and gender were similar between the BC group and RS group. Being widowed, divorced, or unmarried and being neither open nor hostile toward research was associated with an increased likelihood of giving consent. Analysis of personality traits did not show any impact on giving consent.
Overall, this study outlines that there is some bias between BC and RS. Possible associations in BC decisions that offer insights into complex decisions to participate in medical research are marital status, immigrant background, income, and age. Findings emphasize the potential of BC for outpatient research, warranting further investigation to optimize its application in the general practice setting.
在德国，为利用电子健康记录进行研究而收集广泛同意（BC）的重要性日益凸显，这使得人们开始关注在这一过程中对潜在选择偏倚进行更深入理解的必要性。自2020年以来，贝奥内特 - 哈雷门诊数据库一直在收集来自德国各地初级保健和专科诊所的匿名和假名患者数据，诊所是这项数据收集工作的一个组成部分。该试点研究的主要目的是探讨提供BC的患者与普通诊所人群之间潜在的社会经济差异。
这是一项单中心横断面研究。该研究针对来自一个医疗保健中心（包括八名全科医生）的患者进行。我们将在2021年3月至2023年1月期间与全科医生至少有过一次互动的患者分为两组：批准BC的患者与随机选择的非BC询问者代表性样本（RS）。我们向两组邮寄了一份社会人口学调查问卷。
共分析了561名患者，BC组的回应率（60.7%）高于RS组（29.7%）。BC组和RS组的年龄和性别相似。丧偶、离异或未婚且对研究既不开放也不敌对与同意的可能性增加有关。人格特质分析未显示对同意有任何影响。
总体而言，本研究概述了BC组和RS组之间存在一些偏倚。在BC决策中可能存在的关联，这些关联为参与医学研究的复杂决策提供了见解，包括婚姻状况、移民背景、收入和年龄。研究结果强调了BC在门诊研究中的潜力，值得进一步调查以优化其在普通诊所环境中的应用。
